Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 75
Updated:4/2/2016
Start Date:December 2012
End Date:January 2016
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

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Trial Summary
Trial Overview
Inclusion Criteria

A Multi-Center, Randomized, Double-Blind, Placebo and Active-Controlled Study With Exploratory DR to Investigate the Efficacy and Safety of 16 Wks Treatment With s.c. QGE031 in Asthma Patients Not Adequately Controlled With High-dose Inhaled Corticosteroids and Long Acting β2-agonists

This study will assess the effect on asthma control of different dose levels and regimens of
QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2
agonist medication. Safety will also be assessed. Comparison will be to placebo and
omalizumab. Information from this study will inform the design of future studies.


Key Inclusion Criteria:

- A diagnosis of allergic asthma , uncontrolled on current medication.

- History of at least 1 asthma exacerbation during the last 1 year

- Forced Expiratory Volume in one second (FEV1) of ≥ 40% and ≤ 80% of the predicted
normal value; reversibility following administration of bronchodilator must also be
demonstrated (historical positive reversibility or bronchoprovocation result can be
used).

Key Exclusion Criteria:

- Baseline IgE levels or body weight outside the omalizumab dosing table.

- Use of tobacco products within the previous 6 months (Social occasional smokers may
be included).

- Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.
We found this trial at
36
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Novartis Investigative Site
San Jose, California 95117
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Arlington, Texas 76012
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Baltimore, Maryland 21287
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Billings, Montana 59102
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Bowling Green, Kentucky 42101
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Brooklyn, New York 11218
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Cincinnati, Ohio 45229
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Cleveland, Ohio 44109
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Columbia, Maryland 21044
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Evansville, Indiana 47713
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Everett, Washington 98208
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Fairfax, Virginia 22031
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Fairfax, VA
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Fresno, California 93710
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Hawaiian Gardens, California 90716
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Lincoln, Rhode Island 02865
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Lynn Haven, Florida 32444
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Medford, Oregon 97504
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Mineola, New York 11501
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Minneapolis, Minnesota 55402
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Mobile, Alabama 36693
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Mt. Pleasant, South Carolina 29464
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Novi, Michigan 48374
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Omaha, Nebraska 68144
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Owensboro, Kentucky 42301
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Papillion, Nebraska 68046
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Pensacola, Florida 32504
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Pensacola, Florida 32504
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Philadelphia, Pennsylvania 19102
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Riverside, California 92506
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Salt Lake City, Utah 84103
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Savannah, Georgia 31406
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Spokane, Washington 99202
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Summerville, South Carolina 29485
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Vista, California 92083
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Waldorf, Maryland 20602
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Washington, District of Columbia 20007
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